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Hydrochlorothiazide

HYDROCHLOROTHIAZIDE TABLETS, USP25 mg and 50 mg

Approved
Approval ID

6d7e3b52-e26e-4e62-aa2e-31c87a6cd5bd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 20, 2012

Manufacturers
FDA

Legacy Pharmaceutical Packaging

DUNS: 143213275

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68645-341
Application NumberANDA040412
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification

INGREDIENTS (6)

HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Hydrochlorothiazide - FDA Drug Approval Details